Table 2.
Relationship between PSA at diagnosis and features related to tumor significance in biopsy specimens (placebo group only).*
| PSA value (ng/ml) | |||||
|---|---|---|---|---|---|
| 0-1.0 | 1.1-2.5 | 2.6-4.0 | 4.1-10.0 | > 10 | |
| No. of subjects | 161 | 352 | 192 | 238 | 12 |
| Gleason score | 5.98 (0.54) 6 | 6.08 (0.61) 6 | 6.43 (0.95) 6 | 6.55 (0.94) 6 | 6.92 (1.16) 7 |
| No. cores positive | 1.32 (0.63) 1 | 1.61 (0.90) 1 | 2.02 (1.44) 2 | 2.17 (1.56) 2 | 2.00 (1.13) 2 |
| Percent cores positive | 20.0 (10.0) 16.7 | 25.7 (14.7) 16.7 | 31.2 (19.2) 25.0 | 32.1 (20.0) 27.3 | 32.5 (19.0) 26.7 |
| Greatest linear extent (mm) | 1.63 (1.48) 1.10 | 2.24 (2.04) 1.60 | 3.09 (2.64) 2.25 | 3.55 (3.23) 2.60 | 3.91 (3.32) 3.70 |
| Aggregate linear extent (mm) | 2.06 (2.39) 1.15 | 3.29 (3.97) 1.80 | 5.37 (7.39) 3.00 | 6.54 (8.71) 3.40 | 6.25 (7.32) 5.05 |
| Bilateral | 8.7% | 15.6% | 21.5% | 26.0% | 33.3% |
| Perineural invasion | 1.2% | 8.3% | 13.4% | 12.5% | 0.0% |
| Median prostate volume | 27.2 cc | 31.9 cc | 36.1 cc | 40.0 cc | 31.9 cc |
| Median PSA density (ng/ml/gm) | 0.03 | 0.05 | 0.09 | 0.12 | 0.48 |
| Insignificant Cancer (%) (Criteria 1)1 | 51.7% | 33.7% | 17.8% | 11.7% | 0.0% |
| Insignificant Cancer (%) (Criteria 2)2 | 55.4% | 38.8% | 17.2% | 13.5% | 0.0% |
*
Numbers represent means, (standard deviation), and medians from top to bottom unless otherwise noted.
1
Stage T1c + PSA density < 0.15 ng/ml/cc + Gleason score ≤6 (no pattern 4 or 5) + tumor limited to < 3 cores + no core with greater than 50% involvement.
2
Stage T1c + PSA density < 0.15 ng/ml/cc + Gleason score ≤(no pattern 4 or 5) + tumor limited to < 3 mm on 1 core.